AEs n (%) | PBO + FORSequential(n=59) | PBO + FOR Combined(n=55) | REV + FOR Sequential(n=63) | REV + FORCombined(n=62) |
Current smoker | 4 (12.5)(n=32) | 1 (3.6)(n=28) | 1 (2.7)(n=37) | 1 (2.8)(n=36) |
Former smoker | 3 (11.1)(n=27) | 5 (18.5)(n=27) | 2 (7.7)(n=26) | 4 (15.4)(n=26) |
GOLD 3/4 | 2 (10.0)(n=20) | 1 (5.3)(n=19) | 2 (8.0)(n=25) | 0(n=25) |
Aged ≥65 years | 4 (14.3)(n=28) | 5 (17.9)(n=28) | 2 (8.7)(n=23) | 4 (17.4)(n=23) |
Aged <65 years | 3 (9.7)(n=31) | 1 (3.7)(n=27) | 1 (2.5)(n=40) | 1 (2.6)(n=39) |
Current ICS use | 3 (20.0)(n=15) | 2 (14.3)(n=14) | 0(n=13) | 1 (7.7)(n=13) |
No current ICS use | 4 (9.1)(n=44) | 4 (9.8)(n=41) | 3 (6.0)(n=50) | 4 (8.2)(n=49) |
Reversible to ipratropium | 4 (12.1)(n=33) | 4 (13.3)(n=30) | 2 (6.7)(n=30) | 2 (6.9)(n=29) |
Not reversible to ipratropium | 3 (11.5)(n=26) | 2 (8.0)(n=25) | 1 (3.0)(n=33) | 3 (9.1)(n=33) |
Trough FEV1 from baseline, LS change (mL) | Trough FEV1 from baseline, LS change (mL | PBO + FOR Combined(n=59) | REV + FOR Sequential(n=63) | REV + FORCombined(n=63) |
Current smoker | 30.5 (42.4)(n=27) | −9.5 (42.9)(n=26) | 205.3 (41.3)(n=32) | 159.1 (41.0)(n=33) |
Former smoker | 75.6 (41.6)(n=27) | 77.6 ( 41.6)(n=27) | 98.7 (42.8)(n=25) | 63.1 (42.3)(n=26) |
GOLDb 3 and 4 | 75.1 (47.8)(n=19) | 65.3 (48.4)(=18) | 168.4 (47.9)(n=22) | 118.5 (47.2)(n=23) |
Aged >65 years | 33.4 (43.4)(n=28) | 30.5 (43.4)(n=28) | 66.0 (47.3)(n=22) | 68.6 (46.7)(n=23) |
Aged ≤65 years | 74.1 (43.0)(n=26) | 38.2 (43.5)(n=25) | 231.3 (38.7)(n=35) | 162.0 (38.5)(n=36) |
Current ICS use | -37.3 (57.5)(n=14) | -19.47 (58.6)(n=13) | 96.3 (62.3)(n=11) | 128.2 (60.7)(n=12) |
No current ICS use | 116.6 (33.7)(n=40) | 86.22 (33.7)(n=40) | 207.30 (31.5)(n=46) | 147.97 (31.3)(n=47) |
Reversible to ipratropium | 45.7 (39.3)(n=30) | 30.0 (39.3)(n=30) | 253.5 (43.4)(n=27) | 170.5 (42.8)(n=28) |
Not reversible to ipratropium | 67.2 (43.9)(n=24) | 45.5 (44.6)(n=23) | 79.6 (39.1)(n=30) | 75.1 (38.7)(n=31) |
aAEs were collected from days 1 to 42. b2017 GOLD criteria. cFEV1 was collected in the morning at baseline and on days 21 and 42. n= evaluable n. AE, adverse event; FEV1, forced expiratory volume in 1 second; FOR, formoterol; GOLD, Global Obstructive Lung Disease; ICS, inhaled corticosteroids; LS, least squares; PBO, placebo; REV, revefenacin, SE, standard error.